Regulatory Associate

Role: Regulatory Associate Location: Bishopstown, Cork Benefits: Top salary, Hybrid working, bonus, pension and healthcare Company: My client are an innovative Cork-based med‑tech spin‑out disrupting paediatric ENT care with a streamlined, in‑office ear‑tube insertion device. They've scaled from Irish clinical success to U.S. regulatory approval and global roll‑out under a German multinational company. With a strong IP portfolio, seasoned leadership, and growing market presence, they’re well-positioned to change the standard of care in paediatric ear surgery. Role: You will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. You must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate Responsibilities: Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.Assist in the implementation of MDSAP within the organisation.Support the team to obtain / retain country-specific regulatory registrations on a global basis.Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.Work closely with QA for internal and external audits, including notified body audits as required.Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions.Provide strategic regulatory insight to team members regarding product development plansMaintain the day-to-day activities of Post Market Surveillance, including, but not limited to: working collaboratively with (Parent company)logging customer complaints and adverse eventscoordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as requiredregulatory trending and reporting activities as required Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulationsMaintaining awareness of global regulatory legislation and assess its impact on business and product development programsKeep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.Support the team with CE mark submissions, significant change notifications and Notified Body interactions.Support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.Carry out other regulatory related duties as required. Required Education & Experience: Bachelor’s degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.Regulatory certifications in EU MDR and US FDA desirable.Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CRF 820 and supporting standards.Proven track record with the ability to successfully manage projects to deadlinesExperience working directly with regulatory agenciesStrong ability to manage critical projects as part of an interdisciplinary teamExcellent problem solving and communication skillsMust be self-motivated, highly organised and detail-orientedExcellent oral and written communication skillsMust be able to work as part of a cross functional teamThrives to work in a fast-paced / entrepreneurial environment To apply for more info call me on 087 060 8656 or email colin.clare@lifescience.ie